United Therapeutics asks FDA not to approve a Liquidia NDA for Yutrepia because the sole supplier of active pharmaceutical ingredients to Liquidia is ...
A California federal court tosses a shareholder class action suit claiming that AcelRx deliberately used marketing materials for its Dsuvia opioid pai...
FDA issues a complete response letter for a Dynavax sBLA for a new indication for its Heplisav-B hepatitis vaccine.
FDA clears an Indica Labs 510(k) for HALO AP Dx, a digital pathology platform that the company says enables slides to be reviewed from any location as...
Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for made during January, February, and March.
FDA says CTK Biotechs ImmuView Covid-19 Antigen Home Test now has a longer shelf life than previously authorized.
FDA extends by three months its review of an Ascendis Pharma NDA for TransCon PTH (palopegteriparatide) due to the companys submission of additional i...
FDA approves Baxters expanded indication for parenteral (intravenous) nutritient Clinolipid (lipid injectable emulsion) for use in pediatric patients,...
